ISO 11179

Integration profiles collaboratively developed by CDISC and IHE for integrating data from Electronic Health Records (EHRs) with clinical research and pharmacovigilance are limited to resolving lexical/syntactic data integration issues and do not address semantic barriers. This paper describes the collaboration between two European projects - EHR4CR and SALUS - in implementing ISO/IEC 11179-based metadata registries (MDRs) and semantically integrated cross-platform data access. A common "semantic MDR" provides a framework for bidirectional/cross-MDR mapping and federated queries are enabled using the newly-defined IHE Data Exchange (DEX) profile...

OBJECTIVES: Classification of data elements (DEs), which is used in clinical documents is challenging, even in across ISO/IEC 11179 compliant clinical metadata registries (MDRs) due to no existence of reliable standard for identifying DEs. We suggest the Clinical Data Element Ontology (CDEO) for unified indexing and retrieval of DEs across MDRs. METHODS: The CDEO was developed through harmonization of existing clinical document models and empirical analysis of MDRs...

Integration and analysis of clinical data collected in multiple data sources over a long period of time is a major challenge even when data warehouses and metadata registries are used. Since most metadata registries focus on describing data elements to establish domain consistent data definition and providing item libraries, hierarchical and temporal dependencies cannot be mapped. Therefore we developed and validated a reference data model, based on ISO/IEC 11179, which allows revision and branching control of conceptually similar data elements with heterogeneous definitions and representations...

OBJECTIVES: Health Avatar Beans was for the management of chronic kidney disease and end-stage renal disease (ESRD). This article is about the DialysisNet system in Health Avatar Beans for the seamless management of ESRD based on the personal health record. METHODS: For hemodialysis data modeling, we identified common data elements for hemodialysis information (CDEHI). We used ASTM continuity of care record (CCR) and ISO/IEC 11179 for the compliance method with a standard model for the CDEHI...

Achieving semantic interoperability is critical for biomedical data sharing between individuals, organizations and systems. The ISO/IEC 11179 MetaData Registry (MDR) standard has been recognized as one of the solutions for this purpose. The standard model, however, is limited. Representing concepts consist of two or more values, for instance, are not allowed including blood pressure with systolic and diastolic values. We addressed the structural limitations of ISO/IEC 11179 by an integrated metadata object model in our previous research...

In order to enable secondary use of Electronic Health Records (EHRs) by bridging the interoperability gap between clinical care and research domains, in this paper, a unified methodology and the supporting framework is introduced which brings together the power of metadata registries (MDR) and semantic web technologies. We introduce a federated semantic metadata registry framework by extending the ISO/IEC 11179 standard, and enable integration of data element registries through Linked Open Data (LOD) principles where each Common Data Element (CDE) can be uniquely referenced, queried and processed to enable the syntactic and semantic interoperability...

In order to support empirical medical research concerning reuse and improvement of the expressiveness of study data and hence promote syntactic as well as semantic interoperability, services are required for the maintenance of data element collections. As part of the project for the implementation of a German metadata repository for empirical research we assessed the ability of ISO/IEC 11179 "Information technology - Metadata registries (MDR)" part 3 edition 3 Final Committee Draft "Registry metamodel and basic attributes" to represent healthcare standards...

The relevance of controlled vocabularies in promoting the standardized representation and exchange of clinical data is no longer to be proved. As part of a national project we evaluated the integration of classifications and terminologies in metadata registries based on the standard ISO/IEC 11179 Information technology - Metadata Registries (MDR). To overcome integration and maintenance tasks of monohierarchical classifications in the MDR, and to provide an exchange format between classifications publishers and the MDR, we implemented an import interface based on the Classification Markup Language (ClaML)...

BACKGROUND: The Tissue Microarray Data Exchange Specification (TMA DES) is an XML specification for encoding TMA experiment data. While TMA DES data is encoded in XML, the files that describe its syntax, structure, and semantics are not. The DTD format is used to describe the syntax and structure of TMA DES, and the ISO 11179 format is used to define the semantics of TMA DES. However, XML Schema can be used in place of DTDs, and another XML encoded format, RDF, can be used in place of ISO 11179...

Empirical medical research needs services for the maintenance of item collections. We evaluated the appropriateness of ISO/IEC 11179 "Information technology - Metadata Registries (MDR)" part 3 "Registry Metamodel and basic attributes" for a national MDR. In particular, possibilities of including classifications and terminologies (summarized as vocabularies) using the metamodel of this standard were assessed. The hierarchical structure of classifications and terminologies could be mapped easily to ISO's metamodel...

BACKGROUND: The Tissue Microarray Data Exchange Specification (TMA DES) is an eXtensible Markup Language (XML) specification for encoding TMA experiment data in a machine-readable format that is also human readable. TMA DES defines Common Data Elements (CDEs) that form a basic vocabulary for describing TMA data. TMA data are routinely subjected to univariate and multivariate statistical analysis to determine differences or similarities between pathologically distinct groups of tumors for one or more markers or between markers for different groups...

Achieving data interoperability between organizations relies upon agreed meaning and representation (metadata) of data. For managing and registering metadata, many organizations have built metadata registries (MDRs) in various domains based on international standard for MDR framework, ISO/IEC 11179. Following this trend, two pubic MDRs in biomedical domain have been created, United States Health Information Knowledgebase (USHIK) and cancer Data Standards Registry and Repository (caDSR), from U.S. Department of Health & Human Services and National Cancer Institute (NCI), respectively...

In order to cope with increasing demands to supply information to a variety of documentation systems outside pathology, pathologists need to set standards both for the content and the use of the information they generate. Oncological datasets based on a set vocabulary are urgently required for use both in pathology and in further processing. Data elements were defined according to German pathology report guidelines for colorectal cancers in line with ISO 11179 requirements for the relations between data element concepts and value domains, as well as for further formal conditions, which can be exported in XML together with metadata information...

OBJECTIVE: For the purpose of establishing electronic health record (EHR), business-oriented health data distributed in different systems should be integrated to focus on individuals. This study is aimed at collecting health data items that are now nationally available in various health information systems, and harmonizing them by modeling and defining the data elements. METHODS: This study followed a bottom-up strategy in data standard development. Health data items were identified and collected by referring to national health service regulations, consulting domain experts and performing field investigations...

The planning of case report forms (CRFs) in clinical trials or databases in registers is mostly an informal process starting from scratch involving domain experts, biometricians, and documentation specialists. The Telematikplattform für Medizinische Forschungsnetze, an umbrella organization for medical research in Germany, aims at supporting and improving this process with a metadata repository, covering the variables and value lists used in databases of registers and trials. The use cases for the metadata repository range from a specification of case report forms to the harmonization of variable collections, variables, and value lists through a formal review...

Standardized management of data elements (DEs) for Case Report Form (CRF) is crucial in Clinical Trials Information System (CTIS). Traditional CTISs utilize organization-specific definitions and storage methods for Des and CRFs. We developed metadata-based DE management system for clinical trials, Clinical and Histopathological Metadata Registry (CHMR), using international standard for metadata registry (ISO 11179) for the management of cancer clinical trials information. CHMR was evaluated in cancer clinical trials with 1625 DEs extracted from the College of American Pathologists Cancer Protocols for 20 major cancers...

OBJECTIVES: The National Cancer Institute (NCI) has developed the Common Data Elements (CDE) to serve as a controlled vocabulary of data descriptors for cancer research, to facilitate data interchange and inter-operability between cancer research centers. We evaluated CDE's structure to see whether it could represent the elements necessary to support its intended purpose, and whether it could prevent errors and inconsistencies from being accidentally introduced. We also performed automated checks for certain types of content errors that provided a rough measure of curation quality...

BACKGROUND: The Cooperative Prostate Cancer Tissue Resource (CPCTR) is a consortium of four geographically dispersed institutions that are funded by the U.S. National Cancer Institute (NCI) to provide clinically annotated prostate cancer tissue samples to researchers. To facilitate this effort, it was critical to arrive at agreed upon common data elements (CDEs) that could be used to collect demographic, pathologic, treatment and clinical outcome data. METHODS: The CPCTR investigators convened a CDE curation subcommittee to develop and implement CDEs for the annotation of collected prostate tissues...

The NCI provides the cancer Data Standards Repository (caDSR) to support development and deployment of CDEs in cancer research. The caDSR, part of the NCI caCORE infrastructure, supports data management workflow requirements and adherence to ISO/IEC 11179 metadata standards. CDEs are developed using standard terminology from caCORE vocabulary services, and are then deployed to multi-site clinical trials data management systems. Here we describe the caDSR and how CDEs are managed and deployed in clinical research...

A heterotrophic and thermotolerant marine bacterium, designated strain T5054, was isolated from a hot spring on the coast of Lutao, Taiwan. It was a strictly aerobic, Gram-negative rod. Cells grown in broth cultures were non-spore-forming and motile by means of one to several polar flagella. It seems that pilus-like structures were produced from both poles of the cells. Strain T5054 required Na+ for growth and exhibited optimal growth at about 45 degrees C, pH 7, and 3-5% NaCl. It contained iso-C15:0 as the most abundant fatty acid and ubiquinone-8 as the only isoprenoid quinone...